- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03847935
Trigger Finger Treatment
February 18, 2019 updated by: ELewis, University of Massachusetts, Lowell
Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement.
This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement.
This can be very debilitating.
Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention.
The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger.
There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.
Study Type
Observational
Enrollment (Actual)
86
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing medical treatment or hand therapy for trigger finger in digits #2-5 at the hand clinic.
Patients were dropped from the study if they had changed to a different treatment.
Description
Inclusion Criteria:
- trigger finger in digit 2-5
Exclusion Criteria:
- if prior treatment for trigger finger, or Trigger thumb
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgery
Patients who underwent surgical release of A1 pulley
|
A1 pulley release of finger
|
corticosteroid injections only
Patients who underwent local corticosteroid injections only, and no other treatment
|
corticosteroid injection to A1 pulley
|
hand therapy only occupational/physical
1 visit: orthosis fabrication, range of motion, nodule and ice massage.
|
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Other Names:
|
Injection and Hand therapy
This group of participants received a combination of corticosteroid injection in the affected finger and one visit of hand therapy.
|
corticosteroid injection to A1 pulley
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Other Names:
|
Modality Hand Therapy
Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis.
|
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis
|
Injection and Modality Hand Therapy
Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities.
|
corticosteroid injection to A1 pulley
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional use using Quick DASH 6 weeks
Time Frame: Day 1, 6 weeks
|
Change from baseline to 6 weeks Quick DASH
|
Day 1, 6 weeks
|
Change in Functional use using Quick DASH 3 months
Time Frame: Day 1, 3 months
|
Change from baseline to 3 months Quick DASH
|
Day 1, 3 months
|
Change in Functional use using Quick DASH 6 months
Time Frame: Day 1, 6 months
|
Change from baseline to 6 months Quick DASH
|
Day 1, 6 months
|
Change in Edema 6 weeks
Time Frame: day 1, 6 weeks
|
Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx
|
day 1, 6 weeks
|
Change in Edema 3 months
Time Frame: day 1, 3 months
|
Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx
|
day 1, 3 months
|
Change in Edema 6 months
Time Frame: day 1, 6 months
|
Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx
|
day 1, 6 months
|
Change in Pain on a likert scale 6 weeks
Time Frame: 1 day, 6 weeks
|
Baseline to 6 weeks pain on a 0-10 scale
|
1 day, 6 weeks
|
Change in Pain on a likert scale 3 months
Time Frame: 1 day, 3 months
|
Baseline to 3 months pain on a 0-10 scale
|
1 day, 3 months
|
Change in Pain on a likert scale 6 months
Time Frame: 1 day, 6 months
|
Baseline to 6 months pain on a 0-10 scale
|
1 day, 6 months
|
Change in Range of motion 6 weeks
Time Frame: 1 day, 6 weeks
|
Baseline to 6 weeks flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
|
1 day, 6 weeks
|
Change in Range of motion 3 months
Time Frame: 1 day, 3 months
|
Baseline to 3 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
|
1 day, 3 months
|
Change in Range of motion 6 months
Time Frame: 1 day, 6 months
|
Baseline to 6 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
|
1 day, 6 months
|
Change in Severity or Grade of triggering 6 weeks
Time Frame: 1 day, 6 weeks
|
Baseline to 6 weeks Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
|
1 day, 6 weeks
|
Change in Severity or Grade of triggering 3 months
Time Frame: 1 day, 3 months
|
Baseline to 3 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
|
1 day, 3 months
|
Change in Severity or Grade of triggering 6 months
Time Frame: 1 day, 6 months
|
Baseline to 6 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
|
1 day, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 10, 2007
Primary Completion (ACTUAL)
December 8, 2012
Study Completion (ACTUAL)
December 8, 2012
Study Registration Dates
First Submitted
February 8, 2019
First Submitted That Met QC Criteria
February 18, 2019
First Posted (ACTUAL)
February 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-12583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans for sharing the IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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